ABSTRACT
Importance: The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery. Objective: To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM. Design, Setting, and Participants: This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023. Intervention: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. Main Outcomes and Measures: The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE). Results: Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007). Conclusions and Relevance: In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.
Subject(s)
Cervical Vertebrae , Riluzole , Humans , Riluzole/therapeutic use , Male , Female , Middle Aged , Double-Blind Method , Cervical Vertebrae/surgery , Aged , Spinal Cord Diseases/surgery , Spinal Cord Diseases/drug therapy , Spondylosis/surgery , Spondylosis/drug therapy , Treatment Outcome , Neuroprotective Agents/therapeutic useABSTRACT
Degenerative Cervical Myelopathy (DCM) is the functional derangement of the spinal cord resulting from vertebral column spondylotic degeneration. Typical neurological symptoms of DCM include gait imbalance, hand/arm numbness, and upper extremity dexterity loss. Greater spinal cord compression is believed to lead to a higher rate of neurological deterioration, although clinical experience suggests a more complex mechanism involving spinal canal diameter (SCD). In this study, we utilized machine learning clustering to understand the relationship between SCD and different patterns of cord compression (i.e. compression at one disc level, two disc levels, etc.) to identify patient groups at risk of neurological deterioration. 124 MRI scans from 51 non-operative DCM patients were assessed through manual scoring of cord compression and SCD measurements. Dimensionality reduction techniques and k-means clustering established patient groups that were then defined with their unique risk criteria. We found that the compression pattern is unimportant at SCD extremes (≤14.5 mm or > 15.75 mm). Otherwise, severe spinal cord compression at two disc levels increases deterioration likelihood. Notably, if SCD is normal and cord compression is not severe at multiple levels, deterioration likelihood is relatively reduced, even if the spinal cord is experiencing compression. We elucidated five patient groups with their associated risks of deterioration, according to both SCD range and cord compression pattern. Overall, SCD and focal cord compression alone do not reliably predict an increased risk of neurological deterioration. Instead, the specific combination of narrow SCD with multi-level focal cord compression increases the likelihood of neurological deterioration in mild DCM patients.
Subject(s)
Cervical Vertebrae , Magnetic Resonance Imaging , Spinal Cord Compression , Humans , Spinal Cord Compression/diagnostic imaging , Spinal Cord Compression/etiology , Male , Female , Middle Aged , Aged , Cervical Vertebrae/diagnostic imaging , Cervical Cord/diagnostic imaging , Spondylosis/diagnostic imaging , Spondylosis/complications , Disease Progression , Machine Learning , AdultABSTRACT
BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) is the most common form of atraumatic spinal cord injury globally. Degeneration of spinal discs, bony osteophyte growth and ligament pathology results in physical compression of the spinal cord contributing to damage of white matter tracts and grey matter cellular populations. This results in an insidious neurological and functional decline in patients which can lead to paralysis. Magnetic resonance imaging (MRI) confirms the diagnosis of DCM and is a prerequisite to surgical intervention, the only known treatment for this disorder. Unfortunately, there is a weak correlation between features of current commonly acquired MRI scans ("community MRI, cMRI") and the degree of disability experienced by a patient. PURPOSE: This study examines the predictive ability of current MRI sequences relative to "advanced MRI" (aMRI) metrics designed to detect evidence of spinal cord injury secondary to degenerative myelopathy. We hypothesize that the utilization of higher fidelity aMRI scans will increase the effectiveness of machine learning models predicting DCM severity and may ultimately lead to a more efficient protocol for identifying patients in need of surgical intervention. STUDY DESIGN/SETTING: Single institution analysis of imaging registry of patients with DCM. PATIENT SAMPLE: A total of 296 patients in the cMRI group and 228 patients in the aMRI group. OUTCOME MEASURES: Physiologic measures: accuracy of machine learning algorithms to detect severity of DCM assessed clinically based on the modified Japanese Orthopedic Association (mJOA) scale. METHODS: Patients enrolled in the Canadian Spine Outcomes Research Network registry with DCM were screened and 296 cervical spine MRIs acquired in cMRI were compared with 228 aMRI acquisitions. aMRI acquisitions consisted of diffusion tensor imaging, magnetization transfer, T2-weighted, and T2*-weighted images. The cMRI group consisted of only T2-weighted MRI scans. Various machine learning models were applied to both MRI groups to assess accuracy of prediction of baseline disease severity assessed clinically using the mJOA scale for cervical myelopathy. RESULTS: Through the utilization of Random Forest Classifiers, disease severity was predicted with 41.8% accuracy in cMRI scans and 73.3% in the aMRI scans. Across different predictive model variations tested, the aMRI scans consistently produced higher prediction accuracies compared to the cMRI counterparts. CONCLUSIONS: aMRI metrics perform better in machine learning models at predicting disease severity of patients with DCM. Continued work is needed to refine these models and address DCM severity class imbalance concerns, ultimately improving model confidence for clinical implementation.
Subject(s)
Cervical Vertebrae , Magnetic Resonance Imaging , Humans , Middle Aged , Male , Cervical Vertebrae/diagnostic imaging , Cervical Vertebrae/surgery , Female , Aged , Severity of Illness Index , Spinal Cord Diseases/diagnostic imaging , Spinal Cord Diseases/surgery , Adult , Machine LearningABSTRACT
BACKGROUND: Despite an abundance of literature on degenerative cervical myelopathy (DCM), little is known about preoperative expectations of these patients. PURPOSE: The primary objective was to describe patient preoperative expectations. Secondary objectives included identifying patient characteristics associated with high preoperative expectations and to determine if expectations varied depending on myelopathy severity. STUDY DESIGN: This was a retrospective study of a prospective multicenter, observational cohort of patients with DCM. PATIENT SAMPLE: Patients who consented to undergo surgical treatment between January 2019 and September 2022 were included. OUTCOMES MEASURES: An 11-domain expectation questionnaire was completed preoperatively whereby patients quantified the expected change in each domain. METHODS: The most important expected change was captured. A standardized expectation score was calculated as the sum of each expectation divided by the maximal possible score. The high expectation group was defined by patients who had an expectation score above the 75th percentile. Predictors of patients with high expectations were determined using multivariable logistic regression models. RESULTS: There were 262 patients included. The most important patient expectation was preventing neurological worsening (40.8%) followed by improving balance when standing or walking (14.5%), improving independence in everyday activities (10.3%), and relieving arm tingling, burning and numbness (10%). Patients with mild myelopathy were more likely to select no worsening as the most important expected change compared to patients with severe myelopathy (p<.01). Predictors of high patient expectations were: having fewer comorbidities (OR -0.30 for every added comorbidity, 95% CI -0.59 to -0.10, p=.01), a shorter duration of symptoms (OR 0.92, 95% CI 0.35-1.19, p=.02), no contribution from "failure of other treatments" on the decision to undergo surgery (OR 1.49, 95% CI 0.56-2.71, p=.02) and more severe neck pain (OR 0.19 for 1 point increase, 95% CI 0.05-0.37, p=.01). CONCLUSIONS: Most patients undergoing surgery for DCM expect prevention of neurological decline, better functional status, and improvement in their myelopathic symptoms. Stopping neurological deterioration is the most important expected outcomes by patients.
Subject(s)
Cervical Vertebrae , Spinal Cord Diseases , Humans , Male , Female , Middle Aged , Spinal Cord Diseases/surgery , Spinal Cord Diseases/psychology , Cervical Vertebrae/surgery , Aged , Canada , Retrospective Studies , Prospective Studies , Preoperative Period , Surveys and QuestionnairesABSTRACT
STUDY DESIGN: Retrospective cohort study of prospectively accrued data. OBJECTIVE: To evaluate a large, prospective, multicentre dataset of surgically-treated DCM cases on the contemporary risk of C5 palsy with surgical approach. SUMMARY OF BACKGROUND DATA: The influence of surgical technique on postoperative C5 palsy after decompression for degenerative cervical myelopathy (DCM) is intensely debated. Comprehensive analyses are needed using contemporary data and accounting for covariates. METHODS: Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012, to May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy. RESULTS: A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients that underwent posterior decompression compared to anterior decompression (11.26% vs. 3.03%, P=0.008). After multivariable regression, posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy (P=0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches. CONCLUSION: The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM. LEVEL OF EVIDENCE: Therapeutic Level II.
ABSTRACT
BACKGROUND AND OBJECTIVES: There is a lack of data examining the effects of perioperative adverse events (AEs) on long-term outcomes for patients undergoing surgery for degenerative cervical myelopathy. We aimed to investigate associations between the occurrence of perioperative AEs and coprimary outcomes: (1) modified Japanese Orthopaedic Association (mJOA) score and (2) Neck Disability Index (NDI) score. METHODS: We analyzed data from 800 patients prospectively enrolled in the Canadian Spine Outcomes and Research Network multicenter observational study. The Spine AEs Severity system was used to collect intraoperative and postoperative AEs. Patients were assessed at up to 2 years after surgery using the NDI and the mJOA scale. We used a linear mixed-effect regression to assess the influence of AEs on longitudinal outcome measures as well as multivariable logistic regression to assess factors associated with meeting minimal clinically important difference (MCID) thresholds at 1 year. RESULTS: There were 167 (20.9%) patients with minor AEs and 36 (4.5%) patients with major AEs. The occurrence of major AEs was associated with an average increase in NDI of 6.8 points (95% CI: 1.1-12.4, P = .019) and reduction of 1.5 points for mJOA scores (95% CI: -2.3 to -0.8, P < .001) up to 2 years after surgery. Occurrence of major AEs reduced the odds of patients achieving MCID targets at 1 year after surgery for mJOA (odds ratio 0.23, 95% CI: 0.086-0.53, P = .001) and for NDI (odds ratio 0.34, 95% CI: 0.11-0.84, P = .032). CONCLUSION: Major AEs were associated with reduced functional gains and worse recovery trajectories for patients undergoing surgery for degenerative cervical myelopathy. Occurrence of major AEs reduced the probability of achieving mJOA and NDI MCID thresholds at 1 year. Both minor and major AEs significantly increased health resource utilization by reducing the proportion of discharges home and increasing length of stay.
Subject(s)
Cervical Vertebrae , Patient Reported Outcome Measures , Postoperative Complications , Spinal Cord Diseases , Humans , Male , Female , Middle Aged , Canada/epidemiology , Aged , Cervical Vertebrae/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Spinal Cord Diseases/surgery , Cohort Studies , Treatment Outcome , Prospective StudiesABSTRACT
BACKGROUND AND OBJECTIVES: The advantages and disadvantages of anterior vs posterior surgical approaches for patients with progressive degenerative cervical myelopathy (DCM) remain uncertain. Our primary objective was to evaluate patient-reported disability at 1 year after surgery. Our secondary objectives were to evaluate differences in patient profiles selected for each approach in routine clinical practice and to compare neurological function, neck and arm pain, health-related quality of life, adverse events, and rates of reoperations. METHODS: We analyzed data from patients with DCM who were enrolled in an ongoing multicenter prospective observational cohort study. We controlled for differences in baseline characteristics and numbers of spinal levels treated using multivariable logistic regression. Adverse events were collected according to the Spinal Adverse Events Severity protocol. RESULTS: Among 559 patients, 261 (47%) underwent anterior surgery while 298 (53%) underwent posterior surgery. Patients treated posteriorly had significantly worse DCM severity and a greater number of vertebral levels involved. After adjusting for confounders, there was no significant difference between approaches for odds of achieving the minimum clinically important difference for the Neck Disability Index (odds ratio 1.23, 95% CI 0.82 to 1.86, P = .31). There was also no significant difference for change in modified Japanese Orthopedic Association scores, and differences in neck and arm pain and health-related quality of life did not exceed minimum clinically important differences. Patients treated anteriorly experienced greater rates of dysphagia, whereas patients treated posteriorly experienced greater rates of wound complications, neurological complications, and reoperations. CONCLUSION: Patients selected for posterior surgery had worse DCM and a greater number of vertebral levels involved. Despite this, anterior and posterior surgeries were associated with similar improvements in disability, neurological function, pain, and quality of life. Anterior surgery had a more favorable profile of adverse events, which suggests it might be a preferred option when feasible.
ABSTRACT
STUDY DESIGN: Systematic Review and Meta-Analysis. OBJECTIVES: This study aimed to evaluate the clinical and radiological outcomes of surgically treated adjacent segment disease (ASDis) following ACDF with either anterior plate construct (APC) or stand-alone anchored spacers (SAAS). METHOD: Multiple databases were searched until December 2022 for pertinent studies. The primary outcome was health-related quality of life outcomes [JOA, NDI, and VAS], whereas, the secondary outcomes included operative characteristics [estimated blood loss (EBL) and operative time (OT)], radiological outcomes [C2-C7 Cobb angle, disc height index (DHI) changes, fusion rate], and complications. RESULTS: A total of 5 studies were included, comprising 210 patients who had been surgically treated for cervical ASDis. Among them, 113 received APC, and 97 received SAAS. Postoperative dysphagia was significantly higher in the APC group [47% vs 11%, OR = 7.7, 95% CI = 3.1-18.9, P < .05]. Similarly, operative time and blood loss were higher in the APC group compared to the SAAS group; [MD = 16.96, 95% CI = 7.87-26.06, P < .05] and [MD = 5.22, 95% CI = .35 - 10.09, P < .05], respectively. However, there was no difference in the rate of prolonged dysphagia and clinical outcomes in terms of JOA, NDI, and VAS. Furthermore, there was no difference in the radiological parameters including the C2-7 Cobb angle and DHI as well as the fusion rate. CONCLUSION: Our meta-analysis demonstrated that both surgical techniques (APC and SAAS) are effective in treating ASDis. However, with low certainty of the evidence, considering patients are at high risk of dysphagia following revision cervical spine surgery SAAS may be the preferred choice.
ABSTRACT
BACKGROUND CONTEXT: Existing degenerative cervical myelopathy (DCM) severity scales have significant shortcomings, creating a strong impetus for the development of a practical measurement tool with sound psychometric properties. PURPOSE: This work reports the item generation and reduction of the Cervical Myelopathy Severity Index (CMSI), a new DCM patient-reported outcome measure of symptoms and functional limitations. DESIGN: Prospective observational study. PATIENT SAMPLE: Adult DCM patients belonging to one of three distinct treatment groups: (1) observation cohort, (2) preoperative surgical cohort, (3) 6 to 12 months postoperative cohort. OUTCOME MEASURES: Patient-reported outcome measure of symptoms and functional limitations. METHODS: Item generation was performed using semi-structured patient focus groups emphasizing symptoms experienced and functional limitations. Readability was assessed through think-aloud patient interviews. Item reduction involved surveys of DCM patients with a spectrum of disease severity and board-certified spine surgeons experienced in the treatment of DCM. A priori criteria for item removal included: patient median importance/severity <2 (of 4), 30% or more no severity (response of zero), item severity correlations ≤ 0.80 (Spearman), item severity reliability (weighted kappa <0.60) based on a 2-week interval and clinician median importance <2 with retention of items with very high clinical importance. RESULTS: There were 42 items generated from a combination of specialist input and patient focus groups. Items captured sensorimotor symptoms and limitations related to upper and lower extremities as well as sphincter dysfunction. Ninety-eight patients (43, 30, 25 observation, pre- and postsurgery respectively) and 51 surgeons completed the assessment. Twenty-three items remained after application of median importance and severity thresholds and weighted kappa cutoffs. After elimination of highly correlated (>0.80) items and combining two similar items, the final CMSI questionnaire list included 14 items. CONCLUSIONS: The CMSI is a new DCM patient-reported clinical measurement tool developed using patient and clinician input to inform item generation and reduction. Future work will evaluate the reliability, validity, and responsiveness of the CMSI in relation to existing myelopathy measurement indices.
Subject(s)
Spinal Cord Diseases , Adult , Humans , Reproducibility of Results , Spinal Cord Diseases/diagnosis , Spinal Cord Diseases/surgery , Psychometrics , Patient Reported Outcome Measures , Prospective Studies , Cervical Vertebrae/surgeryABSTRACT
OBJECTIVE: Lumbosacral pseudoarthrosis is a common complication following adult spine deformity (ASD) surgery. This study assessed the reoperation rate for L5-S1 pseudoarthrosis in the ASD population. Compared with transforaminal lumbar interbody fusions (TLIFs), we hypothesized that anterior lumbar interbody fusion (ALIF) would result in lower rates of L5-S1 pseudarthrosis. METHODS: This is a single center study with patient data retrieved from a prospective ASD database. The patients had a long-segment fusion, ALIF or TLIF at the L5-S1 level with a 2-year follow-up and were divided into 2 groups (TLIF and ALIF). The study's primary outcome was to assess the difference in the reoperation rate for clinical pseudoarthrosis between the TLIF and the ALIF groups. The secondary outcomes measured the radiological pseudoarthrosis rate and identified risks for L5-S1 pseudoarthrosis development. RESULTS: A total of 100 patients were included; 49 patients (mean age, 62.9 years; 77.5% females) were in TLIF and 51 patients (mean age, 64.4 years; 70.6% females) were in the ALIF group. Baseline characteristics were similar in both groups. Thirteen (13%) patients with L5-S1 pseudoarthrosis required reoperation. Clinical pseudoarthrosis was higher in the TLIF group than in the ALIF group (12/49 vs. 1/51; P < 0.001). Univariate analysis demonstrated a higher risk of L5-S1 pseudoarthrosis with TLIF than ALIF (risk ratio, 12.4; 95% confidence interval: 1.68-92.4; P < 0.001). Multivariate analysis revealed 4.86 times the risk of L5-S1 clinical pseudoarthrosis with TLIF than with ALIF (risk ratio, 4.86; 95% confidence interval 0.57-47; P = 0.17), but this ratio did not reach statistical significance. CONCLUSIONS: No difference in reoperation risk for L5-S1 pseudarthrosis was observed based on the method of IF. rhBMP-2 was noted as a significant predictor.
Subject(s)
Pseudarthrosis , Spinal Fusion , Female , Humans , Adult , Middle Aged , Male , Spinal Fusion/adverse effects , Spinal Fusion/methods , Lumbar Vertebrae/surgery , Pseudarthrosis/etiology , Pseudarthrosis/surgery , Retrospective Studies , Prospective Studies , Treatment OutcomeABSTRACT
STUDY DESIGN: A Prospective cohort study. OBJECTIVE: To investigate the incidence, etiology, and outcomes of patients who experience neurological deterioration after surgery for Degenerative Cervical Myelopathy (DCM). SUMMARY OF BACKGROUND DATA: Postoperative neurological deterioration is one of the most undesirable complications that can occur after surgery for DCM. METHODS: We analyzed data from the Canadian Spine Outcomes and Research Network DCM prospective cohort study. We defined postoperative neurological deterioration as any decrease in modified Japanese Orthopaedic Association (mJOA) score by at least one point from baseline to three months after surgery. Adverse events were collected using the Spinal Adverse Events Severity protocol. Secondary outcomes included patient-reported pain, disability, and health-related quality of life. RESULTS: Among a study cohort of 428 patients, 50 (12%) deteriorated by at least one mJOA point after surgery for DCM (21 by one point, 15 by two points, and 14 by three points or more). Significant risk factors included older age, female sex, and milder disease. Among those who deteriorated, 13 experienced contributing intraoperative or postoperative adverse events, six had alternative non-DCM diagnoses, and 31 did not have an identifiable reason for deterioration. Patients who deteriorated had significantly lower mJOA scores at one year after surgery [13.5 (SD 2.7) vs. 15.2 (SD 2.2), P <0.01 and those with larger deteriorations were less likely to recover their mJOA to at least their preoperative baseline, but most secondary measures of pain, disability, and health-related quality of life were unaffected. CONCLUSIONS: The incidence of deterioration of mJOA scores after surgery for DCM was approximately one in 10, but some deteriorations were unrelated to actual spinal cord impairment and most secondary outcomes were unaffected. These findings can inform patient and surgeon expectations during shared decision-making, and they demonstrate that the interpretation of mJOA scores without clinical context can sometimes be misleading.
Subject(s)
Quality of Life , Spinal Cord Diseases , Humans , Female , Prospective Studies , Cervical Vertebrae/surgery , Canada , Spinal Cord Diseases/surgery , Treatment OutcomeABSTRACT
BACKGROUND: The time course over which postoperative neurological recovery occurs after surgery for degenerative cervical myelopathy occurs is poorly understood. OBJECTIVE: To determine the time point at which patients experience significant neurological improvement. METHODS: We reviewed data from an ongoing prospective multicenter cohort study. We measured neurological function at 3 months, 1 year, and 2 years after surgery using the modified Japanese Orthopedic Association (mJOA) scale. We implemented minimal clinical important differences (MCIDs) to guide interpretation of mJOA scores, and we used 1-way analysis of variance to compare changes between follow-up intervals. RESULTS: Among 330 patients, the mean overall mJOA improved from 12.9 (SD 2.6) to 14.6 (SD 2.4) at 3 months, 14.7 (SD 2.4) at 1 year, and 14.8 (SD 2.5) at 2 years. The difference in means was statistically significant (P < .01) at the interval from baseline to 3 months postoperatively, but not from 3 months to 1 year or 1 year to 2 years. The MCID was reached by 161 patients at 3 months, 32 more at 1 year, and 15 more at 2 years, with a statistically significant difference only at 3 months. Patients with moderate or severe disease reached the MCID more frequently than those with mild disease. CONCLUSION: Among patients who underwent surgery for degenerative cervical myelopathy, most significant neurological improvement occurred by 3 months after surgery. These findings will facilitate valid discussions about postoperative expectations during shared clinical decision making between patients and their surgeons.
Subject(s)
Cervical Vertebrae , Spinal Cord Diseases , Humans , Canada , Cervical Vertebrae/surgery , Cohort Studies , Multicenter Studies as Topic , Prospective Studies , Spinal Cord Diseases/surgery , Treatment OutcomeABSTRACT
BACKGROUND CONTEXT: Unexpected intraoperative positive culture (UIPC) has recently become increasingly common in revision spine surgery, being implicated as an etiological factor in revision spine surgery indications such as implant failure or pseudoarthrosis. PURPOSE: Utilizing the available literature, this study aimed to investigate the prevalence of UIPC, and its clinical importance in patients following presumed aseptic revision spine surgery. STUDY DESIGN: Meta-analysis and systematic review. METHODS: Multiple databases and reference articles were searched until May 2022. The primary outcome was the pooled rate of UIPC, and the secondary outcomes were the microbiological profile of UIPC, the risk factors of UIPC, and the clinical fate of UIPC. RESULTS: Twelve studies were eligible for meta-analysis, with a total of 1,108 patients. The pooled rate of UIPC was 24.3% (95% CI=15.8%-35.5%) in adult patients, and 43.2% (95% CI=32.9%-54.2%) in pediatric patients. The UIPC rate was higher when both conventional wound culture and sonication were used together compared to sonication alone or conventional wound culture alone. The rates were 28.9%, 23.6%, and 15.5 %, respectively. In adult and pediatric patients, the most commonly cultured organism was Cutibacterium acnes (42.5% vs 57.7%), followed by coagulase-negative Staphylococcus (39.9% vs 30.5%). Male patients had a higher rate of UIPC (OR= 2.6, 95% CI=1.84-3.72, p<.001), as did patients with a longer fusion construct (MD=0.76, 95% CI=0.27-1.25, p<.001). CONCLUSIONS: The pooled rate of UIPC in aseptic spine revision surgery was 24.3% and 43.2% in adult and pediatric patients respectively. The most common organisms were C. acnes and coagulase-negative Staphylococcus. The impact of UIPC on patients` clinical outcomes is not fully understood. We are not able to recommend routine culture in revision spine surgery, however, adding sonication may aid in the diagnosis of UIPC. There is not enough evidence to recommend specific treatment strategies at this time, and further studies are warranted.
Subject(s)
Coagulase , Prosthesis-Related Infections , Adult , Humans , Male , Child , Reoperation , Prosthesis-Related Infections/diagnosis , Prosthesis-Related Infections/microbiology , Prosthesis-Related Infections/surgery , Spine/surgery , Risk Factors , Retrospective StudiesABSTRACT
STUDY DESIGN: Ambispective cohort study. OBJECTIVE: Canada has a government-funded universal health care system. The United States utilizes a multitier public and private system. The objective is to investigate differences in clinical outcomes between those surgically treated for lumbar disc herniation in a universal health care and multitier health system. METHODS: Surgical lumbar disc herniation patients enrolled in the Canadian Spine Outcome Research Network (CSORN) were compared with the surgical cohort enrolled in the Spine Patients Outcome Research Trial (SPORT) study. Baseline demographics and spine-related patient-reported outcomes (PROs) were compared at 3 months and 1 year post-operatively. RESULTS: The CSORN cohort consisted of 443 patients; the SPORT cohort had 763 patients. Patients in the CSORN cohort were older (46.4 ± 13.5 vs 41.0 ± 10.8, P < .001) and were more likely to be employed (69.5% vs 60.3%, P = .003). The CSORN cohort demonstrated significantly greater rates of satisfaction after surgery at 3 months (87.2% vs 64.8%, P < .0001) and 1 year (85.6% vs 69.6%, P < .0001). Improvements in back and leg pain followed similar trajectories in the two cohorts, but there was less improvement on ODI in the CSORN cohort (P < .01). On multivariable logistic regression, the CSORN cohort was a significant independent predictor of patient satisfaction at 1-year follow-up (P < .001). CONCLUSIONS: Despite less improvement on ODI, patients enrolled in CSORN, as part of a universal health care system, reported higher rates of satisfaction at 3 months and 1 year post-operatively compared to patients enrolled within a multitier health system.
ABSTRACT
STUDY DESIGN: Retrospective cohort study. OBJECTIVE: We evaluated the effectiveness of minimally invasive (MIS) tubular discectomy in comparison to conventional open surgery among patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN). METHODS: We performed an observational analysis of data that was prospectively collected. We implemented Minimum Clinically Important Differences (MCIDs), and we adjusted for potential confounders with multiple logistic regression. Adverse events were collected according to the Spinal Adverse Events Severity (SAVES) protocol. RESULTS: Three hundred thirty-nine (62%) patients underwent MIS tubular discectomy and 211 (38%) underwent conventional open discectomy. There were no significant differences between groups for improvement of leg pain and disability, but the MIS technique was associated with reduced odds of achieving the MCID for back pain (OR 0.66, 95% CI 0.44 to 0.99, P < 0.05). We identified statistically significant differences in favor of MIS for each of operating time (MIS mean (SD) 72.2 minutes (30.0) vs open 93.5 (40.9)), estimated blood loss (MIS 37.9 mL (36.7) vs open 76.8 (71.4)), length of stay in hospital (MIS 73% same-day discharge vs open 40%), rates of incidental durotomy (MIS 4% vs open 8%), and wound-related complications (MIS 3% vs open 9%); but not for overall rates of reoperation. CONCLUSIONS: Open and MIS techniques yielded similar improvements of leg pain and disability at up to 12 months of follow-up, but MIS patients were less likely to experience improvement of associated back pain. Small differences favored MIS for operating time, blood loss, and adverse events but may have limited clinical importance.
ABSTRACT
OBJECTIVE: In multilevel posterior cervical instrumented fusion, extension of fusion across the cervicothoracic junction (CTJ) at T1 or T2 has been associated with decreased rates of reoperation and pseudarthrosis but with longer surgical time and increased blood loss. The impact on patient-reported outcomes (PROs) remains unclear. The primary objective was to determine whether extension of fusion through the CTJ influenced PROs at 3, 12, and 24 months after surgery. The secondary objective was to compare the number of patients who reached the minimal clinically important differences (MCIDs) for the PROs, modified Japanese Orthopaedic Association (mJOA) score, operative time, intraoperative blood loss, length of stay, discharge disposition, adverse events (AEs), reoperation within 24 months of surgery, and patient satisfaction. METHODS: This was a retrospective observational cohort study of prospectively collected multicenter data of patients with degenerative cervical myelopathy. Patients who underwent posterior instrumented fusion of 4 levels or greater (between C2 and T2) between January 2015 and October 2020 and received 24 months of follow-up were included. PROs (scores on the Neck Disability Index [NDI], EQ-5D, physical component summary and mental component summary of SF-12, and numeric rating scale for arm and neck pain) and mJOA scores were compared using ANCOVA and adjusted for baseline differences. Patient demographic characteristics, comorbidities, and surgical details were abstracted. The proportions of patients who reached the MCIDs for these outcomes were compared with the chi-square test. Operative duration, intraoperative blood loss, AEs, reoperation, discharge disposition, length of stay, and satisfaction was compared by using the chi-square test for categorical variables and the independent-samples t-test for continuous variables. RESULTS: A total of 198 patients were included in this study (101 patients with fusion not crossing the CTJ and 97 with fusion crossing the CTJ). Patients with a construct extending through the CTJ were more likely to be female and have worse baseline NDI scores (p > 0.05). When adjusted for baseline differences, there were no statistically significant differences between the two groups in terms of the PROs and mJOA scores at 3, 12, and 24 months. Surgical duration was longer (p < 0.001) and intraoperative blood loss was greater in the group with fusion extending to the upper thoracic spine (p = 0.013). There were no significant differences between groups in terms of AEs (p > 0.05). Fusion with a construct crossing the CTJ was associated with reoperation (p = 0.04). Satisfaction with surgery was not significantly different between groups. The proportions of patients who reached the MCIDs for the PROs were not statistically different at any time point. CONCLUSIONS: There were no statistically significant differences in PROs between patients with a posterior construct extending to the upper thoracic spine and those without such extension for as long as 24 months after surgery. The AE profiles were not significantly different, but longer surgical time and increased blood loss were associated with constructs extending across the CTJ.
ABSTRACT
OBJECTIVE: Degenerative cervical myelopathy (DCM) is an important public health issue. Surgery is the mainstay of treatment for moderate and severe DCM. Delayed discharge of patients after DCM surgery is associated with increased healthcare costs. There is a paucity of data regarding predictive factors for discharge destination after scheduled surgery for patients with DCM. The purpose of this study was to identify factors predictive of home versus nonhome discharge after DCM surgery. METHODS: Patients undergoing scheduled DCM surgery who had been enrolled in a prospective DCM substudy of the Canadian Spine Outcomes and Research Network registry between January 2015 and October 2020 were included in this retrospective analysis. Patient data were evaluated to identify potential factors predictive of home discharge after surgery. Logistic regression was used to identify independent factors predictive of home discharge. A multivariable model was then used as a final model. RESULTS: Overall, 639 patients were included in the initial analysis, 543 (85%) of whom were discharged home. The mean age of the entire cohort was 60 years (SD 11.8 years), with a BMI of 28.9 (SD 5.7). Overall, 61.7% of the patients were female. The mean length of stay was 2.72 days (SD 1.7 days). The final internally validated bootstrapped multivariable model revealed that younger age, higher 9-Item Patient Health Questionnaire score, lower Neck Disability Index scores, fewer operated levels, mJOA scores indicating mild disease, anterior cervical discectomy and fusion procedure, and no perioperative adverse effects were predictive of home discharge. CONCLUSIONS: Younger age, less neck-related disability, fewer operated levels, more significant depression, less severe myelopathy, anterior cervical discectomy and fusion procedure, and no perioperative adverse effects are predictive of home discharge after surgery for DCM. These factors can help to guide clinical decision-making and optimize postoperative care pathways.
ABSTRACT
Men often make riskier decisions than women across a wide range of real-life behaviors. Whether this sex difference is accentuated, diminished, or stable under stressful conditions is, however, contested in the scientific literature. A critical blind spot lies amid this contestation: Most studies use standardized, laboratory-based, cognitive measures of decision making rather than complex real-life social simulation tasks to assess risk-related behavior. To address this blind spot, we investigated the effects of acute psychosocial stress on risk decision making in men and women (N = 80) using a standardized cognitive measure (the Iowa Gambling Task; IGT) and a novel task that simulated a real-life social situation (an online chatroom in which participants interacted with other men and women in sexually suggestive scenarios). Participants were exposed to either an acute psychosocial stressor or an equivalent control condition. Stressor-exposed participants were further characterized as high- or low-cortisol responders. Results confirmed that the experimental manipulation was effective. On the IGT, participants characterized as low-cortisol responders (as well as those in the Non-Stress group) made significantly riskier decisions than those characterized as high-cortisol responders. Similarly, in the online chatroom, participants characterized as low-cortisol responders (but not those characterized as high-cortisol responders) were, relative to those in the Non-Stress group, significantly more likely to make risky decisions. Together, these results suggest that at lower levels of cortisol both men and women tend to make riskier decisions in both economic and social spheres.
ABSTRACT
STUDY DESIGN: Uncontrolled retrospective observational study. OBJECTIVES: Surgery for patients with back pain and degenerative disc disease is controversial, and studies to date have yielded conflicting results. We evaluated the effects of lumbar fusion surgery for patients with this indication in the Canadian Spine Outcomes and Research Network (CSORN). METHODS: We analyzed data that were prospectively collected from consecutive patients at 11 centers between 2015 and 2019. Our primary outcome was change in patient-reported back pain at 12 months of follow-up, and our secondary outcomes were satisfaction, disability, health-related quality of life, and rates of adverse events. RESULTS: Among 84 patients, we observed a statistically significant improvement of back pain at 12 months that exceeded the threshold of Minimum Clinically Important Difference (MCID) (mean change -3.7 points, SD 2.6, p < 0.001, MCID = 1.2; 77% achieved MCID), and 81% reported being "somewhat" or "extremely" satisfied. We also observed improvements of Oswestry Disability Index (-17.3, SD 16.6), Short Form-12 Physical Component Summary (10.3, SD 9.6) and Short Form-12 Mental Component Summary (3.1, SD 8.3); all p < 0.001). The overall rate of adverse events was 19%. CONCLUSIONS: Among a highly selective group of patients undergoing lumbar fusion surgery for degenerative disc disease, most experienced a clinically significant improvement of back pain as well as significant improvements of disability and health-related quality of life, with high satisfaction at 1 year of follow-up. These findings suggest that surgery for this indication may provide some benefit, and that further research is warranted.
ABSTRACT
STUDY DESIGN: Retrosepctive analysis of prospectively collected data from the multicentre Canadian Surgical Spine Registry (CSORN). OBJECTIVE: Degenerative cervical myelopathy (DCM) is the most common cause of spinal cord dysfunction in North America. Few studies have evaluated return to work (RTW) rates after DCM surgery. Our goals were to determine rates and factors associated with postoperative RTW in surgically managed patients with DCM. METHODS: Data was derived from the prospective, multicenter Canadian Spine Outcomes and Research Network (CSORN). From this cohort, we included all nonretired patients with at least 1-year follow-up. The RTW rate was defined as the proportion of patients with active employment at 1 year from the time of surgery. Unadjusted and adjusted analyses were used to identify patient characteristics, disease, and treatment variables associated with RTW. RESULTS: Of 213 surgically treated DCM patients, 126 met eligibility, with 49% working and 51% not working in the immediate period before surgery; 102 had 12-month follow-up data. In both the unadjusted and the adjusted analyses working preoperatively and an anterior approach were associated with a higher postoperative RTW (P < .05), there were no significant differences between the postoperative employment groups with respect to age, gender, preoperative mJOA (modified Japanese Orthopaedic Association) score, and duration of symptoms (P > .05). Active preoperative employment (odds ratio = 15.4, 95% confidence interval = 4.5, 52.4) and anterior surgical procedures (odds ratio = 4.7, 95% confidence interval = 1.2, 19.6) were associated with greater odds of RTW at 1 year. CONCLUSIONS: The majority of nonretired patients undergoing surgery for DCM had returned to work 12 months after surgery; active preoperative employment and anterior surgical approach were associated with RTW in this analysis.